The Post-ICU Pain Study

NCT07180407 | Recruiting

• 1 other identifier: PIP-study
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 4

Brief Summary

BACKGROUND: ICU survivors may experience serious psychological, physical and cognitive impairments following ICU admission, collectively termed Post Intensive Care Syndrome (PICS). Persistent pain is an underrecognized component of PICS. Previous research has shown that persistent pain is a profound clinical challenge in ICU survivors, however, research demonstrates conflicting results. Furthermore, no studies have examined the prevalence of persistent pain in ICU survivors in a contemporary Danish ICU setting. OBJECTIVES: We aim to examine the clinical trajectory, risk factors, and pathophysiology of persistent pain in ICU survivors in Denmark. DESIGN AND SAMPLE SIZE: The study is designed as a multicenter, prospective, inception cohort study with clinical follow-up. Based on the pre-study sample size calculation, 800 patients will be included. Patients will be contacted by telephone 90 days and 180 days after ICU discharge, and a series of questionnaires regarding pain, sleep quality, affective state and quality of life will be completed. A subgroup of patients will undergo a detailed clinical examination including quantitative sensory testing between 180-365 days after ICU discharge. POPULATION: Patients will be recruited from 4 Danish ICU departments. Inclusion criteria include adult patients (18 years of age), acute admission to the ICU, and an ICU admission of a minimum of 48 hours. OUTCOMES: The primary outcome is the prevalence of pain assessed by the Brief Pain Inventory (BPI) at 90 and 180 days after ICU discharge. Secondary outcomes include additional detailed descriptions of pain and daily activity, sleep quality, affective state, quality of life, treatment- and patient-related risk factors, and biomarkers associated with development of persistent pain. Substudies: \- QST substudy: 80 participants (40 with pain and 40 without pain) recruited from the main cohort will undergo Quantative Somatosensory Testing (QST). The objectives are first, to delineate somatosensory profiles of ICU survivors with and without pain, and second, to examine the presence of neuropathic pain in ICU survivors.

Conditions

Chronic Pain; Post Intensive Care Unit Syndrome; Quality of Life; Pain Disorder

Keywords

intensive care units; chronic pain; sleep disorder; anxiety and depression; icu survivors

Outcome Measures

Primary Outcomes (1)

• Prevalence of pain

  Patients are defined as having pain if they answer "yes" to question number 1 in the Brief Pain Inventory - Short Form

  180 day follow-up

Secondary Outcomes (9)

• Brief Pain Inventory - Short Form (BPI-SF)

  At follow-up at 90 and 180 days

• Incidence of new-onset persistent pain after ICU discharge

  at 90 and 180 days follow-up

• Quality of life measured by EuroQol-5-domain 5-level (EQ-5D-5L)

  at 90 and 180 days

• The Single Item Sleep Quality Scale (SQS)

  at 90 and 180 days

• Hospital Anxiety and Depression Scale (HADS)

  at 90 and 180 days

Other Outcomes (7)

• The Short Physical Performance Battery (SPPB)

  between 180 days followup and 360 days.

• PainDETECT (PD-Q)

  between 180 days followup and 360 days

• QST outcomes

  between 180 days followup and 360 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the ICU

You may qualify if:

• Adult ICU patients ≥18 years of age
• Acute admission to the ICU
• ICU length of stay of at least 48 hours

You may not qualify if:

• Patients transferred from a non-participating ICU
• Patients with pre-planned admission to the ICU e.g., following elective surgery
• Patients unable to complete questionnaires, including those who are unable to understand or speak Danish, or patients with severe cognitive deficits.

Sponsors & Collaborators

• Zealand University Hospital: lead
• Aalborg University Hospital: collaborator

Study Sites (4)

Aalborg University Hospital

Aalborg, 9000, Denmark

NOT YET RECRUITING

Zealand University Hospital

Køge, 4600, Denmark

RECRUITING

Zealand University Hospital

Nykøbing Falster, 4800, Denmark

RECRUITING

Zealand University Hospital

Roskilde, 4000, Denmark

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Somatoform Disorders; Sleep Wake Disorders; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Nervous System Diseases; Behavioral Symptoms; Behavior

Central Study Contacts

Bennedikte K Madsen, MD

CONTACT

0045; bkom@regionsjaelland.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: September 18, 2025
• Study Start: September 23, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-09

Locations

DK (4)